[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20537-20542]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8550]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0063; FRL-8867-5]
Etoxazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project
4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 13, 2011. Objections and
requests for hearings must be received on or before June 13, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0063. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0063 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 13, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0063, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-for Tolerance
In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7675)
by IR-4, Rutgers, The State University of New Jersey, 500 College Road
East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40
CFR part 180 be amended by establishing tolerances for residues of the
miticide/ovicide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-
dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on peppers,
African eggplant, eggplant, martynia, okra, pea eggplant, pepino,
roselle, and scarlet eggplant at 0.20 ppm; Crop Group 9: Cucurbit
vegetables at 0.20 ppm; Subgroup 13-07A: Caneberry at 1.1 ppm; Subgroup
13-07F: Small fruit vine climbing subgroup except fuzzy kiwi at 0.50
ppm; Subgroup 13-07G: Low-growing berry subgroup at 0.50 ppm and
avocado, papaya, star apple, black sapote, mango, sapodilla, canistel,
and mamey sapote at 0.20 ppm; and tea at 15 ppm. The petition also
proposed to delete the established tolerances in or on strawberry,
grape, cucumber, and vegetable, cucurbit subgroup 9A since
[[Page 20538]]
they would be covered by the proposed new tolerances. That notice
referenced a summary of the petition prepared by Valent, the
registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being set and
is setting a subgroup tolerance instead of separate tolerances for some
commodities. It was also determined that the proposed deletion of the
cucurbit subgroup 9A and establishment of a tolerance for the cucurbit
vegetables crop group 9 could not be done due to differences in
tolerance levels between subgroups 9A and 9B. Finally, the tolerance
expression is being revised to be consistent with current Agency
policy. The reasons for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for etoxazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with etoxazole
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The existing etoxazole data indicate that it possesses low acute
toxicity via all routes of exposure. It is not an eye or dermal
irritant or a dermal sensitizer. No toxicity was seen at the limit dose
in a 28-day dermal toxicity study in rats.
The liver is the main target organ in mice, rats and dogs. In a 90-
day toxicity study in dogs, increased liver weights and centrilobular
hepatocellular swelling in the liver were observed. Similar effects
were observed in a chronic toxicity study in dogs at similar doses,
indicating that systemic effects (mainly liver effects) occur at
similar dose levels following short- through long-term exposure without
increasing in severity. In a 90-day toxicity study in mice,
hepatotoxicity (increased relative liver weight, liver enlargement, and
centrilobular hepatocellular swelling) was observed at high doses.
Similar effects were observed at the high dose in a mouse
carcinogenicity study. Subchronic and chronic toxicity studies in rats
produced similar effects (increased liver weights, centrilobular
hepatocellular swelling, etc.) to those seen in mice and dogs. In
addition, slight increases in thyroid weights and incisors were
observed in subchronic and chronic toxicity studies in rats at high
doses and at terminal stages of the study. Toxicity was not observed at
the highest dose tested (HDT) in another carcinogenicity study in mice.
There is no evidence of immunotoxicity or neurotoxicity in any of the
submitted studies.
Two studies in mice showed no evidence of carcinogenicity up to the
HDT. In a rat carcinogenicity study, which was deemed unacceptable due
to inadequate dosing, benign interstitial cell tumors (testis) and
pancreas benign islet cell adenomas were observed (in females) at the
high dose. These effects were not observed in an acceptable
carcinogenicity study in rats at higher doses. In special mechanistic
male rat studies there were no observable changes in serum hormone
levels (estradiol, luteinizing hormone (LH), prolactin and
testosterone) or reproductive effects (interstitial cell proliferation
or spermatogenesis) noted. EPA classified etoxazole as ``not likely to
be carcinogenic to humans.'' Etoxazole is not mutagenic.
The toxicology data for etoxazole provides no indication of
increased susceptibility, as compared to adults, of rat and rabbit
fetuses to in utero exposure in developmental studies. The rabbit
developmental toxicity study included maternal toxic effects (liver
enlargement, decreased weight gain, and decreased food consumption) at
the same dose as developmental effects (increased incidences of 27
presacral vertebrae and 27 presacral vertebrae with 13th ribs). In the
2-generation reproduction study conducted with rats, offspring toxicity
was more severe (pup mortality) than parental toxicity (increased liver
and adrenal weights) at the same dose, indicating increased qualitative
susceptibility.
Specific information on the studies received and the nature of the
adverse effects caused by etoxazole as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-0063 in the
document titled Etoxazole; ``Human Health Risk Assessment for Proposed
Tolerances and Uses on Peppers (Bell and Non-bell); Squash/Cucumbers
(Subgroup 9B); Avocado; Tropical and Subtropical Fruits (Inedible
Peel); Caneberry Subgroup 13-07A; Small Fruit Vine Climbing, Except
Kiwifruit, Subgroup 13-07F; Low-growing Berry, Subgroup 13-07G; and
Tea,'' pp. 29-31.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency
[[Page 20539]]
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for etoxazole used for
human risk assessment is shown in the following Table:
Table--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (Females 13-50 years of A dose and endpoint attributable to a single dose were not identified in
age and general population including the database including the developmental toxicity studies.
infants and children).
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Chronic dietary (All populations).... NOAEL = 4.62 mg/kg/day Chronic RfD = 0.046 mg/ Chronic Oral Toxicity
UFA = 10x. kg/day. Study-Dog LOAEL = 23.5
UFH = 10x.............. cPAD = 0.046 mg/kg/day. mg/kg/day based upon
FQPA SF = 1x........... increased alkaline
phosphatase activity,
increased liver
weights, liver
enlargement (females),
and incidences of
centrilobular
hepatocellular
swelling in the liver.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).... Classification: ``Not likely to be Carcinogenic to Humans.''
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFDB = to account for the absence of data or other data deficiency.
FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in 40 CFR
180.593. EPA assessed dietary exposures from etoxazole in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
etoxazole; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys for Food Intake by Individuals (CSFII). As
to residue levels in food, an unrefined, chronic dietary exposure
assessment was performed for the general U.S. population and various
population subgroups using tolerance-level residues for all
agricultural commodities and 100 percent crop treated (PCT).
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, Cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or non-linear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that etoxazole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etoxazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etoxazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of etoxazole for
chronic exposures for non-cancer assessments are estimated to be 4.761
parts per billion (ppb) for surface water and 0.318 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 4.761 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Etoxazole is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found etoxazole to share a common mechanism of toxicity
with any other substances, and etoxazole does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that etoxazole does not
have a
[[Page 20540]]
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10x, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. The toxicology data for
etoxazole provides no indication of increased susceptibility, as
compared to adults, of rat and rabbit fetuses to in utero exposure in
developmental studies. In a rat reproduction study, offspring toxicity
was more severe (pup mortality) than parental toxicity (increased liver
and adrenal weights) at the same dose; thereby indicating increased
qualitative susceptibility. Based on the concerns in this unit, a
Degree of Concern Analysis was performed by EPA, which concluded that
concern is low since:
i. The effects in pups are well-characterized with a clear NOAEL;
ii. The pup effects occur at the same dose as parental toxicity;
and
iii. The doses selected for various risk assessment scenarios are
lower (~3000-fold lower) than the doses that caused offspring toxicity
in the rat 2-generation reproduction study. Therefore, the endpoints
selected for risk assessment are protective of the effects seen in the
rat reproduction study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for etoxazole is complete except for acute
and subchronic neurotoxicity and immunotoxicity studies. Changes to 40
CFR 180.158 make acute and subchronic neurotoxicity testing (OPPTS
Guideline 870.6200), and immunotoxicity testing (OPPTS Guideline
870.7800) required for pesticide registration. Although these studies
are not yet available for etoxazole, the available data do not show any
evidence of treatment-related effects on the immune system. Further,
there is no evidence of neurotoxicity in any study in the toxicity
database for etoxazole. Therefore, EPA does not believe that conducting
neurotoxicity and immunotoxicity studies will result in a NOAEL lower
than the NOAEL of 4.62 mg/kg/day already established for etoxazole.
Consequently, an additional database uncertainty factor does not need
to be applied.
ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. Although there is qualitative evidence of increased
susceptibility of offspring (pup mortality) compared to less severe
parental effects (increased liver and adrenal weights) at the same dose
in the rat multi-generation reproduction study, the Agency did not
identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs (10x for interspecies variation and 10x
for intraspecies variation) to be used in the risk assessment.
Therefore, there are no residual concerns regarding developmental
effects in the young.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to etoxazole in drinking water. These assessments
will not underestimate the exposure and risks posed by etoxazole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 11% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for etoxazole.
3. Short and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
A short- and/or intermediate-term adverse effect was identified;
however, etoxazole is not registered for any use patterns that would
result in short- and/or intermediate-term residential exposure. Short-
and/or intermediate-term risk is assessed based on short- and/or
intermediate term residential exposure plus chronic dietary exposure.
Because there is no short- and/or intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess short- and/or intermediate-term risk), no
further assessment of short- and/or intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short- and/or intermediate-term risk for etoxazole.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, etoxazole is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to etoxazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) and gas chromatography/mass selective
detection (GC/MSD) methods) are available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
[[Page 20541]]
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for etoxazole for the
commodities discussed in this document.
C. Response to Comments
EPA received a comment from a private citizen expressing concerns
for genetically modified vegetables and undue risks from pesticides.
However, this action does not involve use of genetically modified
vegetables. Additionally, when new or amended tolerances are requested
for the presence of the residues of a pesticide and its toxicologically
significant metabolite(s) in food or feed, the Agency, as is required
by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA),
estimates the risk of the potential exposure to these residues by
performing an aggregate risk assessment. Such a risk assessment
integrates the individual assessments that are conducted for food,
drinking water, and residential exposures. Additionally, the Agency, as
is further required by section 408 of the FFDCA, considers available
information concerning what are termed the cumulative toxicological
effects of the residues of that pesticide and of other substances
having a common mechanism of toxicity with it. The Agency has concluded
after this assessment that there is a reasonable certainty that no harm
will result from exposure to the residues of interest. Therefore, the
proposed tolerances are found to be acceptable. These assessments
consider body residue loads of the pesticide, as well as available
information concerning the potential that other substances have a
common mechanism of toxicity, in reaching a conclusion as to whether or
not the reasonable certainty of no harm decision can be made.
D. Revisions to Petitioned-for Tolerances
Upon review of the data supporting the petition, EPA revised the
tolerance for caneberry subgroup 13-07A from 1.1 ppm to 1.5 ppm based
on analysis of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data.
The Agency also corrected the commodity definition from ``fruit,
small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit'' to
``fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-
07F.''
EPA has also determined that the petitioned-for tolerance on tea at
15 ppm should be established as a tolerance with no U.S. registrations
on tea, dried at 15 ppm. At least one U.S. residue field trial study is
required to establish a domestic registration on tea; however, no U.S.
residue field trial data were submitted in support of the use of
etoxazole on tea. Therefore, the Agency has established a tolerance
with no U.S. registrations on tea, dried at 15 ppm.
Additionally, IR-4 petitioned for individual tolerances on peppers,
African eggplant, eggplant, martynia, okra, pea eggplant, pepino,
roselle, and scarlet eggplant (PP 9E7675). In the Federal Register of
December 8, 2010 (75 FR 76284-76292) (FRL-8853-8), EPA issued a final
rule that revised the crop grouping regulations. As part of this
action, EPA retained the pre-existing Crop Group 8 and added a new
group titled ``Crop Group 8-10 Fruiting Vegetable Group.'' The new crop
group 8-10 added new commodities and created new subgroups (including a
subgroup consisting of the commodities requested in PP 9E7675). EPA
indicated in the December 8, 2010 final rule as well as the earlier
January 6, 2010 proposed rule (75 FR 807) (FRL-8801-2) that, for
existing petitions for which a Notice of Filing had been published, the
Agency would attempt to conform these petitions to the rule. Therefore,
consistent with this rule, EPA is establishing a tolerance on the
pepper/eggplant subgroup 8-10B. EPA concludes it is reasonable to
establish the tolerance on the newly created subgroup, since the
individual commodities for which tolerances were requested are
identical to those which comprise the pepper/eggplant subgroup 8-10B.
Also, because of differences in the tolerance levels between
subgroup 9A (melon subgroup) and 9B (squash/cucumber subgroup), the two
cannot be combined into a single tolerance under Crop Group 9 Cucurbit
Vegetables as proposed in the petition. Accordingly, other than the
nomenclature change to the existing subgroup 9A tolerance noted below,
EPA is leaving the existing subgroup 9A tolerance intact and adding a
new tolerance for subgroup 9B. In order to use the correct
nomenclature, the existing tolerance for ``vegetable, cucurbit subgroup
9A'' is being re-named ``melon subgroup 9A.''
Finally, EPA has revised the tolerance expression to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of etoxazole not specifically
mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on pepper/eggplant subgroup 8-10B at 0.20 ppm;
tea, dried at15 ppm; berry, low growing, subgroup 13-07G at 0.50 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
0.50 ppm; squash/cucumber subgroup 9B at 0.02 ppm; avocado at 0.20 ppm;
papaya at 0.20 ppm; star apple at 0.20 ppm; sapote, black at 0.20 ppm;
mango at 0.20 ppm; sapodilla at 0.20 ppm; canistel at 0.20 ppm; sapote,
mamey at 0.20 ppm; and caneberry subgroup 13-07A at 1.5 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety
[[Page 20542]]
Risks (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 1, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.593 is amended by:
0
i. Revising the introductory text in paragraph (a);
0
ii. Removing the commodities ``Cucumber,'' ``Grape'' and ``Strawberry''
from the table in paragraph (a);
0
iii. Revising the entry ``Vegetable, cucurbit subgroup 9A'' to read
``Melon subgroup 9A'' in the table; and
0
iv. Alphabetically adding the following commodities to the table in
paragraph (a) to read as follows:
Sec. 180.593 Etoxazole; tolerances for residues.
(a) General. Tolerances are established for residues of etoxazole,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only etoxazole (2-(2,6-
difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole) in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Avocado................................................... 0.20
Berry, low growing, subgroup 13-07G....................... 0.50
Caneberry subgroup 13-07A................................. 1.5
Canistel.................................................. 0.20
* * * * *
Fruit, small vine climbing, except fuzzy kiwifruit, 0.50
subgroup 13-07F..........................................
* * * * *
Mango..................................................... 0.20
Melon subgroup 9A......................................... 0.20
* * * * *
Papaya.................................................... 0.20
Pepper/eggplant subgroup 8-10B............................ 0.20
* * * * *
Sapodilla................................................. 0.20
Sapote, black............................................. 0.20
Sapote, mamey............................................. 0.20
* * * * *
Squash/cucumber subgroup 9B............................... 0.02
Star apple................................................ 0.20
* * * * *
Tea, dried *.............................................. 15
* * * * *
------------------------------------------------------------------------
* There are currently no U.S. registrations for tea as of April 13,
2011.
* * * * *
[FR Doc. 2011-8550 Filed 4-12-11; 8:45 am]
BILLING CODE 6560-50-P